Programming systems for eliciting evoked responses in a cochlear implant patient and performing predetermined actions in accordance with the evoked responses

ABSTRACT

An exemplary system includes 1) a programming device configured to be located external to a cochlear implant patient and communicatively coupled to a cochlear implant system associated with the patient, 2) a programming interface device communicatively coupled to the programming device and configured to be located external to the patient, and 3) a receiver communicatively coupled directly to the programming interface device. The programming device directs at least one of the cochlear implant system and the receiver to apply stimulation to the patient, records an evoked response that occurs in response to the stimulation, and performs a predetermined action in accordance with the evoked response. Corresponding systems and methods are also disclosed.

RELATED APPLICATIONS

The present application claims priority to U.S. Provisional PatentApplication No. 61/614,129, filed on Mar. 22, 2012, and entitled“Methods and Systems for Fitting an Electro-acoustic Stimulation Systemto a Patient,” the contents of which are hereby incorporated byreference in their entirety.

BACKGROUND INFORMATION

The effectiveness of a cochlear implant system may be affected by anumber of different factors. For example, surgical complications (e.g.,a misalignment of an electrode array within the cochlea, destruction ofhair cells during implantation of a cochlear implant, etc.) andpost-surgery complications (e.g., residual hearing loss, wax buildup inthe ear, infections, and component failure) may be detrimental tocochlear implant system performance. Unfortunately, many of thesefactors are not readily discernible, thereby making it difficult orimpossible to account for them (e.g., by adjusting one or more controlparameters governing an operation of the cochlear implant system).Hence, a patient may unknowingly suffer from sub-optimal cochlearimplant system performance.

Moreover, some patients already fitted with a cochlear implant systemmay be candidates for an electro-acoustic stimulation (“EAS”) system(i.e., a system that provides both electrical and acoustic stimulation).It would be desirable to objectively test whether a patient is acandidate for an EAS system before upgrading the patient's cochlearimplant system to an EAS system.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments and are a partof the specification. The illustrated embodiments are merely examplesand do not limit the scope of the disclosure. Throughout the drawings,identical or similar reference numbers designate identical or similarelements.

FIG. 1 illustrates an exemplary configuration in which a programmingsystem is communicatively coupled to a cochlear implant system accordingto principles described herein.

FIG. 2 illustrates a schematic structure of the human cochlea accordingto principles described herein.

FIG. 3 illustrates exemplary components of a programming deviceaccording to principles described herein.

FIG. 4 illustrates an exemplary configuration that may be used to recordan evoked response according to principles described herein.

FIG. 5 illustrates another exemplary configuration that may be used torecord an evoked response according to principles described herein.

FIG. 6 shows an exemplary baseline response and two possible evokedresponses according to principles described herein.

FIG. 7 shows an exemplary graph that may be presented by a programmingdevice according to principles described herein.

FIG. 8 illustrates an exemplary method according to principles describedherein.

FIG. 9 illustrates an exemplary computing device according to principlesdescribed herein.

DETAILED DESCRIPTION

Programming systems for eliciting evoked responses in a cochlear implantpatient and performing predetermined actions in accordance with theevoked responses are described herein. As will be described below, anexemplary programming system includes 1) a programming device configuredto be located external to a cochlear implant patient and communicativelycoupled to a cochlear implant system associated with the patient, 2) aprogramming interface device communicatively coupled to the programmingdevice and configured to be located external to the patient, and 3) areceiver communicatively coupled directly to the programming interfacedevice. The programming device directs at least one of the cochlearimplant system and the receiver (e.g., by communicating with thecochlear implant system and/or the receiver by way of the programminginterface device) to apply stimulation to the patient, records an evokedresponse that occurs in response to the stimulation, and performs apredetermined action in accordance with the evoked response.

For example, during a consultation between a cochlear implant patientand a clinician, the clinician may connect a programming system to acochlear implant system being used by the patient. This may be done inany suitable manner. For example, the clinician may connect (e.g., byway of a cable) a programming interface device (e.g., a clinician'sprogramming interface (“CPI”) device) to a sound processor included inthe cochlear implant system. The programming interface device may alsobe connected (e.g., by way of one or more cables) to a programmingdevice (e.g., a personal computer, a handheld device, a mobile computingdevice, etc.) and to a receiver configured to be in communication withan ear of the patient.

In this configuration, the clinician may provide input and/or otherwiseinitiate a programming session in which the programming device directsthe cochlear implant system to apply electrical stimulation to thepatient by way of one or more electrodes included in an electrode arrayimplanted within a cochlea of the patient and/or the receiver to applyacoustic stimulation to the patient. The programming device may thenrecord an evoked response that occurs in response to the electricaland/or acoustic stimulation and compare the evoked response to abaseline response and/or one or more previously recorded evokedresponses. If the evoked response differs from the baseline responseand/or the one or more previously recorded evoked responses (e.g., ifthe evoked response is not within a predetermined range of the baselineresponse and/or the one or more previously recorded evoked responses),the programming device may adjust one or more control parametersgoverning an operation of the cochlear implant system, notify thepatient and/or another user of the potentially problematic evokedresponse, and/or take any other suitable action as may serve aparticular implementation. These and other examples will be described inmore detail below.

By eliciting an evoked response and then performing one or morepredetermined actions in accordance with the evoked response, thesystems and methods described herein may facilitate optimal performanceof a cochlear implant system, assist in evaluating one or moreconditions (e.g., a residual hearing status) of the patient, determinewhether the patient is a candidate for an EAS system, and/or otherwiseprovide benefit to the patient.

As used herein, an “evoked response” may include any type of cochlearresponse and/or neural response. Exemplary cochlear responses include,but are not limited to, cochlear microphonics, summating potentials,otoacoustic emissions, etc. Exemplary neural responses include, but arenot limited to, auditory nerve responses, brainstem responses, compoundaction potentials, frequency following responses, etc.

An evoked response may additionally or alternatively include a stapediusresponse and/or any other type of response that may occur in response toapplication of electrical and/or acoustic stimulation.

Additional or alternative manners in which an evoked response may beelicited are described in more detail in co-pending PCT Application No.PCT/US2013/033605, entitled “Electro-acoustic Stimulation Systems thatPerform Predetermined Actions in Accordance with Evoked Responses,”filed the same day as the present application, and incorporated hereinby reference in its entirety.

FIG. 1 illustrates an exemplary configuration 100 in which a programmingsystem 102 is communicatively coupled to a cochlear implant system 104.Programming system 102 and cochlear implant system 104 may becommunicatively coupled in any suitable manner, including in any of themanners described herein.

As shown, cochlear implant system 104 may include a microphone 106, asound processor 108, a headpiece 110 having a coil disposed therein, acochlear implant 112, and an electrode array 114 with a plurality ofelectrodes 116 disposed thereon. Additional or alternative componentsmay be included within cochlear implant system 104 as may serve aparticular implementation.

As shown, various components of cochlear implant system 104 may belocated external to the patient including, but not limited to,microphone 106, sound processor 108 and headpiece 110. Variouscomponents of cochlear implant system 104 may be implanted within thepatient including, but not limited to, cochlear implant 112 andelectrode array 114. Additional or alternative components may beincluded within cochlear implant system 104 as may serve a particularimplementation.

Microphone 106 may be configured to detect audio signals (i.e., audiocontent) presented to the patient. Microphone 106 may be implemented inany suitable manner. For example, microphone 106 may include a “T-Mic”or the like that is configured to be placed within the concha of the earnear the entrance to the ear canal. Such a microphone may be held withinthe concha of the ear near the entrance of the ear canal by a boom orstalk that is attached to an ear hook configured to be selectivelyattached to sound processor 108. Additionally or alternatively,microphone 106 may be implemented by one or more microphones disposedwithin headpiece 110, one or more microphones disposed within soundprocessor 108, and/or any other suitable microphone as may serve aparticular implementation.

Sound processor 108 (i.e., one or more components included within soundprocessor 108) may be configured to direct cochlear implant 112 togenerate and apply electrical stimulation (also referred to herein as“stimulation current”) representative of one or more audio signals(e.g., one or more audio signals detected by microphone 106, input byway of an auxiliary audio input port, etc.) to one or more stimulationsites associated with an auditory pathway (e.g., the auditory nerve) ofthe patient. Exemplary stimulation sites include, but are not limitedto, one or more locations within the cochlea, the cochlear nucleus, theinferior colliculus, and/or any other nuclei in the auditory pathway. Tothis end, sound processor 108 may process the one or more audio signalsin accordance with a selected sound processing strategy or program togenerate appropriate stimulation parameters for controlling cochlearimplant 112. Sound processor 108 may include or be implemented by abehind-the-ear (“BTE”) unit, a body worn device, and/or any other soundprocessing unit as may serve a particular implementation.

In some examples, sound processor 108 may wirelessly transmitstimulation parameters (e.g., in the form of data words included in aforward telemetry sequence) and/or power signals to cochlear implant 112by way of a wireless communication link 118 between headpiece 110 andcochlear implant 112. It will be understood that communication link 118may include a bi-directional communication link and/or one or morededicated uni-directional communication links.

Headpiece 110 may be communicatively coupled to sound processor 108 andmay include an external antenna (e.g., a coil and/or one or morewireless communication components) configured to facilitate selectivewireless coupling of sound processor 108 to cochlear implant 112.Headpiece 110 may additionally or alternatively be used to selectivelyand wirelessly couple any other external device to cochlear implant 112.To this end, headpiece 110 may be configured to be affixed to thepatient's head and positioned such that the external antenna housedwithin headpiece 110 is communicatively coupled to a correspondingimplantable antenna (which may also be implemented by a coil and/or oneor more wireless communication components) included within or otherwiseassociated with cochlear implant 112. In this manner, stimulationparameters and/or power signals may be wirelessly transmitted betweensound processor 108 and cochlear implant 112 via a communication link118 (which may include a bi-directional communication link and/or one ormore dedicated uni-directional communication links as may serve aparticular implementation).

Cochlear implant 112 may include any type of implantable stimulator thatmay be used in association with the systems and methods describedherein. For example, cochlear implant 112 may be implemented by animplantable cochlear stimulator. In some alternative implementations,cochlear implant 112 may include a brainstem implant and/or any othertype of implant that may be implanted within a patient and configured toapply stimulation to one or more stimulation sites located along anauditory pathway of a patient.

In some examples, cochlear implant 112 may be configured to generateelectrical stimulation representative of an audio signal processed bysound processor 108 (e.g., an audio signal detected by microphone 106)in accordance with one or more stimulation parameters transmittedthereto by sound processor 108. To this end, cochlear implant 112 mayinclude one or more current generators. In some examples, cochlearimplant 112 may include one or more lock-in amplifiers. A lock-inamplifier allows for a relatively high signal-to-noise ratio when theexpected phase and waveform of the evoked response is known ahead oftime.

Cochlear implant 112 may be further configured to apply the electricalstimulation to one or more stimulation sites within the patient via oneor more electrodes 116 disposed along electrode array 114. In someexamples, cochlear implant 112 may include a plurality of independentcurrent sources each associated with a channel defined by one or more ofelectrodes 116. In this manner, different stimulation current levels maybe applied to multiple stimulation sites simultaneously by way ofmultiple electrodes 116.

FIG. 2 illustrates a schematic structure of the human cochlea 200 intowhich electrode array 114 may be inserted. As shown in FIG. 2, thecochlea 200 is in the shape of a spiral beginning at a base 202 andending at an apex 204. Within the cochlea 200 resides auditory nervetissue 206, which is denoted by Xs in FIG. 2. The auditory nerve tissue206 is organized within the cochlea 200 in a tonotopic manner.Relatively low frequencies are encoded at or near the apex 204 of thecochlea 200 (referred to as an “apical region”) while relatively highfrequencies are encoded at or near the base 202 (referred to as a “basalregion”). Hence, electrical stimulation applied by way of electrodesdisposed within the apical region (i.e., “apical electrodes”) may resultin the patient perceiving relatively low frequencies and electricalstimulation applied by way of electrodes disposed within the basalregion (i.e., “basal electrodes”) may result in the patient perceivingrelatively high frequencies. The delineation between the apical andbasal electrodes on a particular electrode lead may vary depending onthe insertion depth of the lead, the anatomy of the patient's cochlea,and/or any other factor as may serve a particular implementation.

Returning to FIG. 1, programming system 102 may include variouscomponents configured to be located external to the patient. As shown,programming system 102 may include a programming device 120, aprogramming interface device 122, and a receiver 124 (also referred toas a “loudspeaker”). Programming system 102 may include additional oralternative components, as will be described below.

Programming device 120 may be implemented by any suitable combination ofcomputing devices including, but not limited to, a fitting station, apersonal computer, a laptop computer, a handheld device, a mobile device(e.g., a mobile phone), and/or any other suitable component as may servea particular implementation. In some examples, programming device 120may provide one or more graphical user interfaces (“GUIs”) (e.g., bypresenting the one or more GUIs by way of a display screen) with which aclinician or other user may interact.

As will be described below, programming device 120 may direct cochlearimplant device 104 and/or receiver 124 to apply stimulation to apatient, record an evoked response that occurs in response to thestimulation, and perform one or more predetermined actions in accordancewith the evoked response. Exemplary predetermined actions that may beperformed by programming device 120 will be described below.

Programming interface device 122 may include any combination of devicesconfigured to facilitate communication between programming device 120and one or more other systems and/or components. For example,programming interface device 122 may facilitate communication betweenprogramming device 120 and cochlear implant system 104, betweenprogramming device 120 and receiver 124, and/or between programmingdevice 120 and any other device or component as may serve a particularimplementation.

In some examples, programming interface device 122 may be implemented bya clinician's programming interface (“CPI”) device that includes one ormore ports configured to facilitate selective and direct connection(e.g., by way of one or more wired cables) to any of the componentsdescribed herein. For example, programming interface device 122 may beselectively and directly connected to programming device 120, soundprocessor 108 of cochlear implant system 104, and/or receiver 124.Additionally or alternatively, programming interface device 122 mayfacilitate wireless communication between any of the componentsdescribed herein.

As shown in FIG. 1, programming interface device 122 may be a standalonedevice (i.e., separate from programming device 120). Alternatively,programming interface device 122 may be integrated into programmingdevice 120.

Receiver 124 may be communicatively coupled directly to programminginterface device 122 and may be configured to be in communication withan ear of the patient. For example, receiver 124 may be integrated intoan earmold configured to be located within the outer ear of the patient.The earmold may include any type of earmold that may be at leastpartially disposed within the outer ear of the patient. For example, theearmold may include an open dome configured to allow the ear to remainpartially open (e.g., an open dome tip made from a soft siliconematerial and configured to resemble a tulip or flower bud), a closeddome configured to entirely close off the ear canal, a foam dome, and/orany other type of dome as may serve a particular implementation. As willbe described in more detail below, receiver 124 may be configured toapply acoustic stimulation to the patient as directed by programmingdevice 120. As shown in FIG. 1, receiver 124 is separate from cochlearimplant system 104 (i.e., not connected directly to sound processor108).

FIG. 3 illustrates exemplary components of programming device 120. Asshown in FIG. 3, programming device 120 may include an evoked responsemanagement facility 302, a processing facility 304, and a storagefacility 306, which may be in communication with one another using anysuitable communication technologies. One or more of facilities 302-306may include one or more computing devices and/or processors configuredto perform one or more of the functions described herein. Facilities302-306 will now be described in more detail.

Evoked response management facility 302 may be configured to perform oneor more evoked response management operations. For example, evokedresponse management facility 302 may be configured to attempt to elicitan evoked response within a patient. This may be performed in anysuitable manner. For example, evoked response management facility 302may direct cochlear implant system 104 and/or receiver 124 to applystimulation to the patient and then determine whether an evoked responseoccurs in response to the stimulation. The presence or absence of anevoked response may be indicative of one or more conditions (e.g., aresidual hearing status of the patient, auditory neuropathy, etc.).

Evoked response management facility 302 may direct cochlear implantsystem 104 and/or receiver 124 (e.g., by way of programming interfacedevice 122) to apply stimulation to the patient in any suitable manner.For example, evoked response management facility 302 may direct cochlearimplant system 104 to apply electrical stimulation to the patient by wayof at least one electrode 116 included in electrode array 114 (i.e., bytransmitting one or more commands to sound processor 108 by way ofprogramming interface device 122 for sound processor 108 to directcochlear implant 112 to apply the electrical stimulation). Theelectrical stimulation may have any suitable characteristic. Forexample, the electrical stimulation may include monopolar stimulation.The electrode to which the electrical stimulation is applied may be anyelectrode located within the cochlea of the patient (e.g., the mostapical electrode included in electrode array 114).

As another example, evoked response management facility 302 may directreceiver 124 to apply acoustic stimulation to the patient. The acousticstimulation may have any suitable characteristic as may serve aparticular implementation. For example, the acoustic stimulation mayinclude a relatively low frequency tone burst (e.g., a 125 Hz toneburst).

As another example, evoked response management facility 302 may directcochlear implant system 104 and receiver 124 to concurrently applyelectrical stimulation and acoustic stimulation to the patient.

Evoked response management facility 302 may determine whether an evokedresponse occurs in response to the stimulation (i.e., the electricaland/or acoustic stimulation) in any suitable manner. For example, evokedresponse management facility 302 may use one or more electrodes tomonitor for and record the evoked response. For example, a cochlearresponse (e.g., cochlear microphonics) may be recorded using one or moreelectrodes positioned within the cochlea (e.g., one or more ofelectrodes 116), one or more electrodes positioned within the roundwindow, and/or one or more electrodes positioned at any other suitablelocation relatively near the cochlea. Likewise, a neural response (e.g.,an auditory nerve response and/or a compound action potential) may berecorded using one or more electrodes positioned within or near thecochlea. It will be recognized that the electrode(s) used to record theevoked response may be disposed on a lead that has been inserted intothe cochlea (e.g., electrode array 114), on a fly lead that has beenpositioned at any other suitable location within the patient, or on anyother lead as may serve a particular implementation.

In some examples, one or more electrodes located external to the patientmay be used to record an evoked response. For example, a brainstemresponse may be recorded using one or more non-invasive electrodes thathave been affixed externally to the head of the patient.

In some examples, evoked response management facility 302 may use amicrophone configured to be located within the ear canal of the patientto detect and record an evoked response (e.g., one or more otoacousticemissions). These and other exemplary configurations that may be used torecord evoked responses will be described in more detail below.

Evoked response management facility 302 may be configured to perform oneor more predetermined actions in accordance with an evoked response thatoccurs in response to the stimulation (or in accordance with an evokedresponse not occurring in response to the stimulation). Exemplarypredetermined actions that may be performed by evoked responsemanagement facility 302 will be described in more detail below.

Processing facility 304 may be configured to perform one or moreprocessing operations. For example, processing facility 304 may performone or more programming and/or fitting operations associated withcochlear implant system 104.

Storage facility 306 may be configured to maintain evoked response data308 generated and/or utilized by evoked response management facility 302and/or processing facility 304. In some examples, programming device 120may store data representative of an evoked response within storagefacility 306. Storage facility 306 may be configured to maintainadditional or alternative data as may serve a particular implementation.

Various configurations that may be used to record various types ofevoked responses will now be described. It will be recognized that theconfigurations described herein are merely illustrative of the variousdifferent configurations that may be used to record evoked responses inaccordance with the systems and methods described herein.

FIG. 4 illustrates an exemplary configuration 400 that may be used torecord an evoked response in accordance with the systems and methodsdescribed herein. Configuration 400 is similar to configuration 100,except that programming system 102 further includes a microphone 402communicatively coupled to programming device 120. Microphone 402 may beconfigured to be located in an ear canal of the patient and may be usedby programming device 120 to detect and record one or more otoacousticemissions that occur in response to electrical and/or acousticstimulation being applied to the patient. As used herein, “otoacousticemissions” refer to sounds generated from within the inner ear inresponse to stimulation. In some examples, otoacoustic emissions may beindicative of inner ear health. For example, if programming device 120does not detect a presence of otoacoustic emissions in response tostimulation, this may be indicative of a damaged or unhealthy inner ear.

Programming device 120 may additionally or alternatively use one or moreelectrodes 116 included in electrode array 114 to record one or moreevoked responses. Exemplary evoked responses that may be recorded usingan electrode disposed within the cochlea, such as one of electrodes 116,include, but are not limited to, neural responses and one or more typesof cochlear responses.

FIG. 5 illustrates another exemplary configuration 500 that may be usedto record an evoked response in accordance with the systems and methodsdescribed herein. Configuration 500 is similar to configuration 100,except that configuration 500 further includes an extra-cochlearelectrode 502 communicatively coupled to cochlear implant 112. WhileFIG. 5 shows extra-cochlear electrode 502 communicatively coupled tocochlear implant 112, it will be recognized that extra-cochlearelectrode 502 may alternatively be coupled to programming system 102(e.g., to programming interface device 522).

Extra-cochlear electrode 502 may include any type of electrode notlocated within the cochlea. For example, extra-cochlear electrode 502may include a ring electrode, an electrode configured to be positionedwithin the round window, a stapedius electrode configured to be incommunication with the stapedius muscle (i.e., coupled to the stapediusmuscle and/or the stapedius tendon), and/or any other suitableelectrode. In some examples, extra-cochlear electrode 502 is disposed ona lead 504 communicatively coupled to cochlear implant system 104.Alternatively, extra-cochlear electrode 502 may be disposed on a portionof electrode array 114 that is not located within the cochlea.

In some examples, the use of an extra-cochlear electrode, such asextra-cochlear electrode 502, may allow for a “normalized” evokedresponse to be recorded while electrode array 114 is inserted duringsurgery. In other words, a surgeon may know that changes in evokedresponses recorded with extra-cochlear electrode 502 are due to realchanges in the source of the evoked responses as opposed to being due tochanges in the relative position of electrode array 114 with respect tothe source of the evoked responses.

In cases where the extra-cochlear electrode 502 is a stapediuselectrode, programming device 120 may use the stapedius electrode torecord a stapedius response associated with the stapedius muscle. Asused herein, a “stapedius response” refers to an evoked responsegenerated when the stapedial muscle contracts in response to stimulation(e.g., electrical stimulation at or above a most comfortable level (“Mlevel”) associated with the patient). Programming device 120 may set amaximum power output (“MPO”) for the acoustic stimulation based on thestapedius response and/or perform any other action in accordance withthe stapedius response as may serve a particular implementation.

Various predetermined actions that may be performed by programmingdevice 120 in accordance with an evoked response (or in accordance witha lack of an occurrence of an evoked response) will now be described. Itwill be recognized that the predetermined actions described herein aremerely illustrative of the many different types of predetermined actionsthat may be performed in accordance with an evoked response.

In some examples, programming device 120 may set (e.g., adjust) one ormore control parameters governing operation of cochlear implant system104 in accordance with an evoked response that occurs in response tostimulation provided by cochlear implant system 104 and/or receiver 124.

For example, programming device 120 may record an evoked response thatoccurs in response to electrical and/or acoustic stimulation and comparethe evoked response to a baseline response and/or one or more previouslyrecorded evoked responses. As used herein, a “baseline response” refersto some type of fixed evoked response that a clinician may consider tobe normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows anexemplary baseline response 602 and two possible evoked responses 604-1and 604-2 that may occur in response to stimulation provided by cochlearimplant system 104 and/or receiver 124. As shown, evoked response 604-1is less than baseline response 602 (i.e., evoked response 604-1 has asteady state amplitude that is less than a steady state amplitude ofbaseline response 602). Conversely, evoked response 604-2 is greaterthan baseline response 602 (i.e., evoked response 604-2 has a steadystate amplitude that is greater than a steady state amplitude ofbaseline response 602).

If the evoked response (e.g., evoked response 604-1) differs from thebaseline response (e.g., baseline response 604-2) and/or the one or morepreviously recorded evoked responses (e.g., if the evoked response isnot within a predetermined range of the baseline response and/or the oneor more previously recorded evoked responses), programming device 120may adjust one or more control parameters governing an operation ofcochlear implant system 104 (e.g., by increasing an amplitude and/orintensity level of the stimulation provided by cochlear implant system104 and/or adjusting one or more other characteristics of thestimulation).

Programming device 120 may additionally or alternatively provide one ormore notifications to the patient and/or another user in accordance withan evoked response that occurs in response to stimulation provided bycochlear implant system 104 and/or receiver 124.

For example, if an evoked response is not within a predetermined rangeof a baseline response and/or one or more previously recorded evokedresponses, programming device 120 may provide the patient and/or anotheruser with a notification. The notification may be an audible alert(e.g., one or more beeps), a visible alert (e.g., a flashing of an LED),a text-based alert, and/or any other type of notification as may serve aparticular implementation. The patient and/or other user may then takeappropriate action.

Programming device 120 may additionally or alternatively evaluate aresidual hearing status of the patient in accordance with an evokedresponse that occurs in response to stimulation provided by cochlearimplant system 104 and/or receiver 124. A variety of different factorsmay affect a residual hearing status of a patient. For example, waxbuildup in the ear, infection, sickness, patient age, and/or any otherfactor may temporarily and/or permanently affect a residual hearingstatus of the patient.

To evaluate the residual hearing status of the patient, programmingdevice 120 may direct receiver 124 to apply acoustic stimulation to thepatient. Programming device 120 may then determine whether an evokedresponse occurs in response to the acoustic stimulation. If an evokedresponse does not occur, programming device 120 may notify the clinicianaccordingly (e.g., by presenting a notification by way of a displaydevice) and/or automatically determine that the patient does not haveany residual hearing.

Conversely, if an evoked response does occur in response to the acousticstimulation, programming device 120 may analyze one or morecharacteristics of the evoked response and, based on the analysis,determine that the patient is a candidate for an EAS system. Forexample, if both a cochlear response and a neural response occur inresponse to the acoustic stimulation, programming device 120 maydetermine that the patient is a candidate for an EAS system. In someexamples, programming device 120 may provide a notification (e.g., byway of a display screen) that the patient is a candidate for an EASsystem.

Programming device 120 may additionally or alternatively evaluate theresidual hearing status of the patient by comparing the evoked responseto a previously recorded evoked response and determine, based on acomparison, that the patient's residual hearing is changing (e.g.,deteriorating). In response, programming device 120 may notify thepatient and/or another user, automatically adjust one or more controlparameters governing an operation of cochlear implant system 104 (e.g.,by increasing an amplitude of stimulation being provided to the user),and/or take any other action as may serve a particular implementation.

In some examples, based on the residual hearing status as determined byprogramming device 120, a clinician or other user may decide to providefurther treatment to the patient. For example, the clinician may decideto apply systemic steroids if a drop in residual hearing is detected.

In some examples, programming device 120 may evaluate the residualhearing status by using the evoked response to measure a two-toneinteraction phenomenon that occurs within the patient. When two or moretones are simultaneously presented to the cochlea, tones not originallycontained in the stimulus can be generated due to active non-linearprocesses in the cochlea. These measurable back-propagated responses arecalled distortion products and are considered to be indicative ofhealthy cochlear activity. They can be recorded acoustically from apatient's ear canal (e.g., otoacoustic emissions) or as electricalpotentials from the neurons of the auditory pathway. Two-tone inhibition(i.e., a decrease in response to one tone in the presence of the secondtone) is another phenomenon that occurs in part, due to cochlearnon-linearity and can be measured using evoked responses.

Programming device 120 may additionally or alternatively use the evokedresponse to determine one or more optimal crossover frequenciesassociated with the patient. As used herein, a “crossover frequency”refers to a boundary frequency that separates frequencies represented tothe patient by acoustic stimulation and frequencies represented to thepatient by electrical stimulation. For example, programming device 120may first determine that the patient is a candidate for an EAS system.Programming device 120 may then determine a crossover frequency to beused by the EAS system by determining that acoustic stimulation evokesrobust hair cell and neural responses until 450 Hz and designating thisfrequency as the crossover frequency (i.e., the apical-most electrodecan start providing electrical stimulation around that frequency).

Programming device 120 may additionally or alternatively use the evokedresponse to detect ectopic stimulation within the patient. As usedherein, “ectopic” stimulation refers to abnormal stimulation thatcochlear implant system 104 may be providing to the patient. Ectopicstimulation may be indicated by equal masking on both sides of anelectrode without reduction on one side. An evoked response may beindicative of ectopic stimulation in any suitable manner. For example,an irregular evoked response may be indicative of ectopic stimulation.

Programming device 120 may additionally or alternatively use the evokedresponse to monitor for possible nerve regeneration within the patient.Nerve regeneration may cause changes in evoked responses over time(e.g., the amplitude of evoked responses may gradually increase overtime). Hence, if programming device 120 detects a gradual increase inamplitude of evoked responses over time, this may be indicative of nerveregeneration. In some examples, programming device 120 may notify thepatient and/or another user of the gradual increase and/or of thepossible nerve regeneration, adjust one or more stimulation parametersaccordingly, and/or take any other action based on the gradual increaseas may serve a particular implementation.

Programming device 120 may additionally or alternatively use the evokedresponse to assess (e.g., detect, characterize, etc.) tinnitus ofcochlear origin in the patient. This may be performed in any suitablemanner.

Programming device 120 may additionally or alternatively use the evokedresponse to assist in placement of electrode array 114 during animplantation procedure (i.e., surgery). For example, programming device120 may record the evoked response during an implantation procedure inwhich electrode array 114 is inserted into the patient and determining,based on the evoked response, that the electrode array should berepositioned within the patient. For example, the evoked response may beabnormally low in amplitude. This may indicate that the electrode array114 is not properly positioned within the cochlea. Programming device120 may provide a notification of this to the surgeon, who may adjust apositioning of electrode array 114 accordingly.

Programming device 120 may additionally or alternatively determine asource (e.g., a location within the cochlea) of one or more evokedresponses. This may facilitate identification of one or more regions ofproperly functioning hair cells, identification of one or more acousticdead regions for purposes of determining crossover frequencies, and/ordetermination of whether the patient is a good candidate forelectro-acoustic stimulation.

To illustrate, programming device 120 may direct receiver 124 to apply aconstant level acoustic stimulus to the patient. While the acousticstimulus is being applied, programming device 120 may use multipleelectrodes 116 included in electrode array 114 to monitor for and recordevoked responses (e.g., cochlear responses) that occur in response tothe acoustic stimulus. Programming device 120 may then differentiallycompare the evoked responses and determine which evoked response has thegreatest amplitude. In some examples, the electrode that records theevoked response that has the greatest amplitude corresponds to a regionwithin the cochlea that is the source of the evoked responses.

In some examples, programming device 120 may present a graph of theamplitudes of the evoked responses across the different electrodes(i.e., an evoked response map) to facilitate identification by aclinician or other user of the source of the evoked responses. Forexample, FIG. 7 shows an exemplary graph 700 that may be presented byprogramming device 120 by way of a display screen associated withprogramming device 120. As shown, graph 700 includes an evoked responsemap 702 that plots the amplitude of the evoked responses measured by aplurality of electrodes. In the particular example of FIG. 7, evokedresponse map 702 includes a peak 704 centered at electrode 10. Byviewing graph 700, a clinician may readily ascertain that the source ofthe evoked responses is a location within the cochlea that correspondsto the position of electrode 10 (e.g., a location associated with afrequency of approximately 750 Hz).

Additionally or alternatively, programming device 120 may automaticallydetermine the source of the evoked responses (e.g., by identifying amaximum value included in an evoked response map similar to evokedresponse map 702). Programming device 120 may then take any appropriateaction based on this determination (e.g., notify the clinician oranother user, adjust one or more control parameters associated withcochlear implant system 104, ascertain whether the user is a candidatefor an EAS system, etc.).

In some examples, programming device 120 may determine that an evokedresponse does not occur in response to stimulation provided by cochlearimplant system 104 and/or receiver 124. Programming device 120 mayaccordingly notify the patient, adjust one or more stimulationparameters, and/or perform one or more other actions as may serve aparticular implementation.

For example, programming device 120 may determine that a compound actionpotential does not occur in response to stimulation provided by cochlearimplant system 104 and/or receiver 124. This may be indicative ofauditory neuropathy, and may affect how cochlear implant system 104 isto be fitted to the patient. In response, programming device 120 mayadjust one or more parameters of the electrical stimulation provided bycochlear implant system 104 and/or perform any other suitable action.

Programming device 120 may perform any other type of predeterminedaction in accordance with an evoked response as may serve a particularimplementation. For example, programming device 120 may present a graphrepresentative of the evoked response by way of a display screen,provide one or more recommendations in accordance with the evokedresponse (e.g., one or more recommendations with respect to setting oneor more stimulation parameters that govern cochlear implant system 104),and/or perform any other suitable action as may serve a particularimplementation.

In some examples, programming device 120 may perform one or morepredetermined actions in accordance with a plurality of evoked responsesrecorded over a period of time. For example, the plurality of evokedresponses, taken as a whole, may be indicative of a change in a residualhearing status of the patient. Programming device 120 may accordinglyadjust one or more stimulation parameters and/or take any other suitablepredetermined action as may serve a particular implementation.

FIG. 8 illustrates an exemplary method 800. While FIG. 8 illustratesexemplary steps according to one embodiment, other embodiments may omit,add to, reorder, and/or modify any of the steps shown in FIG. 8. One ormore of the steps shown in FIG. 8 may be performed by programming system102 and/or any implementation thereof (e.g., programming device 120).

In step 802, a programming system directs at least one of a cochlearimplant system used by a patient and a receiver in communication with anear of the patient to apply stimulation to the patient. Step 802 may beperformed in any of the ways described herein.

In step 804, the programming system records an evoked response thatoccurs in response to the stimulation. Step 804 may be performed in anyof the ways described herein.

In step 806, the programming system performs a predetermined action inaccordance with the evoked response. Step 806 may be performed in any ofthe ways described herein.

In certain embodiments, one or more of the processes described hereinmay be implemented at least in part as instructions embodied in anon-transitory computer-readable medium and executable by one or morecomputing devices. In general, a processor (e.g., a microprocessor)receives instructions, from a non-transitory computer-readable medium,(e.g., a memory, etc.), and executes those instructions, therebyperforming one or more processes, including one or more of the processesdescribed herein. Such instructions may be stored and/or transmittedusing any of a variety of known computer-readable media.

A computer-readable medium (also referred to as a processor-readablemedium) includes any non-transitory medium that participates inproviding data (e.g., instructions) that may be read by a computer(e.g., by a processor of a computer). Such a medium may take many forms,including, but not limited to, non-volatile media, and/or volatilemedia. Non-volatile media may include, for example, optical or magneticdisks and other persistent memory. Volatile media may include, forexample, dynamic random access memory (“DRAM”), which typicallyconstitutes a main memory. Common forms of computer-readable mediainclude, for example, a disk, hard disk, magnetic tape, any othermagnetic medium, a CD-ROM, DVD, any other optical medium, a RAM, a PROM,an EPROM, a FLASH-EEPROM, any other memory chip or cartridge, or anyother tangible medium from which a computer can read.

FIG. 9 illustrates an exemplary computing device 900 that may beconfigured to perform one or more of the processes described herein. Asshown in FIG. 9, computing device 900 may include a communicationinterface 902, a processor 904, a storage device 906, and aninput/output (“I/O”) module 908 communicatively connected via acommunication infrastructure 910. While an exemplary computing device900 is shown in FIG. 9, the components illustrated in FIG. 9 are notintended to be limiting. Additional or alternative components may beused in other embodiments. Components of computing device 900 shown inFIG. 9 will now be described in additional detail.

Communication interface 902 may be configured to communicate with one ormore computing devices. Examples of communication interface 902 include,without limitation, a wired network interface (such as a networkinterface card), a wireless network interface (such as a wirelessnetwork interface card), a modem, an audio/video connection, and anyother suitable interface.

Processor 904 generally represents any type or form of processing unitcapable of processing data or interpreting, executing, and/or directingexecution of one or more of the instructions, processes, and/oroperations described herein. Processor 904 may direct execution ofoperations in accordance with one or more applications 912 or othercomputer-executable instructions such as may be stored in storage device906 or another computer-readable medium.

Storage device 906 may include one or more data storage media, devices,or configurations and may employ any type, form, and combination of datastorage media and/or device. For example, storage device 906 mayinclude, but is not limited to, a hard drive, network drive, flashdrive, magnetic disc, optical disc, random access memory (“RAM”),dynamic RAM (“DRAM”), other non-volatile and/or volatile data storageunits, or a combination or sub-combination thereof. Electronic data,including data described herein, may be temporarily and/or permanentlystored in storage device 906. For example, data representative of one ormore executable applications 912 configured to direct processor 904 toperform any of the operations described herein may be stored withinstorage device 906. In some examples, data may be arranged in one ormore databases residing within storage device 906.

I/O module 908 may be configured to receive user input and provide useroutput and may include any hardware, firmware, software, or combinationthereof supportive of input and output capabilities. For example, I/Omodule 908 may include hardware and/or software for capturing userinput, including, but not limited to, a keyboard or keypad, a touchscreen component (e.g., touch screen display), a receiver (e.g., an RFor infrared receiver), and/or one or more input buttons.

I/O module 908 may include one or more devices for presenting output toa user, including, but not limited to, a graphics engine, a display(e.g., a display screen, one or more output drivers (e.g., displaydrivers), one or more audio speakers, and one or more audio drivers. Incertain embodiments, I/O module 908 is configured to provide graphicaldata to a display for presentation to a user. The graphical data may berepresentative of one or more graphical user interfaces and/or any othergraphical content as may serve a particular implementation.

In some examples, any of the facilities and/or systems described hereinmay be implemented by or within one or more components of computingdevice 900. For example, one or more applications 912 residing withinstorage device 906 may be configured to direct processor 904 to performone or more processes or functions associated with any of the facilitiesand/or systems described herein.

In the preceding description, various exemplary embodiments have beendescribed with reference to the accompanying drawings. It will, however,be evident that various modifications and changes may be made thereto,and additional embodiments may be implemented, without departing fromthe scope of the invention as set forth in the claims that follow. Forexample, certain features of one embodiment described herein may becombined with or substituted for features of another embodimentdescribed herein. The description and drawings are accordingly to beregarded in an illustrative rather than a restrictive sense.

What is claimed is:
 1. A system comprising: a programming deviceconfigured to be located external to a patient and communicativelycoupled to a cochlear implant system associated with the patient, thecochlear implant system comprising a sound processor configured tolocated external to the patient, a cochlear implant configured to beimplanted within the patient, and an electrode array configured to belocated within a cochlea of the patient; a programming interface devicecommunicatively coupled to the programming device and configured to belocated external to the patient; and a receiver communicatively coupleddirectly to the programming interface device by way of a cable thatdirectly connects the receiver to the programming interface device,wherein the receiver is not connected directly to the sound processor;wherein the programming device directs, during a period of time after animplantation procedure in which the electrode array is inserted into thepatient, at least one of the cochlear implant system and the receiver toapply stimulation to the patient, records an evoked response that occursin response to the stimulation, compares the evoked response to anadditional evoked response previously recorded by the programming deviceduring the period of time, determines, based on the comparison, that aresidual hearing status of the patient has deteriorated during theperiod of time, increases, in response to the determination that theresidual hearing status of the patient has deteriorated during theperiod of time, an intensity level of additional stimulation provided bythe cochlear implant system in order to present audio content to thepatient subsequent to the period of time, determines that the residualhearing status of the patient improves subsequent to the period of time,and decreases, in response to the determination that the residualhearing status of the patient improves subsequent to the period of time,the intensity level of the additional stimulation provided by thecochlear implant system.
 2. The system of claim 1, wherein thestimulation comprises electrical stimulation, and wherein theprogramming device directs the cochlear implant system to apply theelectrical stimulation to the patient by way of at least one electrodeincluded in the electrode array.
 3. The system of claim 1, wherein thestimulation comprises acoustic stimulation, and wherein the programmingdevice directs the receiver to apply the acoustic stimulation to thepatient.
 4. The system of claim 1, wherein the stimulation compriseselectrical stimulation and acoustic stimulation, and wherein theprogramming device concurrently directs the cochlear implant system toapply the electrical stimulation to the patient by way of at least oneelectrode included in the electrode array and the receiver to apply theacoustic stimulation to the patient.
 5. The system of claim 1, whereinthe programming device records the evoked response using an electrodeincluded in the electrode array.
 6. The system of claim 1, furthercomprising an extra-cochlear electrode communicatively coupled to atleast one of the programming interface device and the cochlear implantsystem, wherein the programming device records the evoked response usingthe extra-cochlear electrode.
 7. The system of claim 1, furthercomprising: a microphone communicatively coupled directly to theprogramming interface device and configured to be located in an earcanal of the patient; wherein the evoked response comprises one or moreotoacoustic emissions, and the programming device records the one ormore otoacoustic emissions using the microphone configured to be locatedin the ear canal of the patient.
 8. The system of claim 7, wherein theprogramming device presents a graph representative of the evokedresponse by way of a display screen associated with the programmingdevice.
 9. The system of claim 1, wherein the programming device:compares the evoked response to a baseline response; and provides atleast one of the patient and another user with a notification if theevoked response is not within a predetermined range of the baselineresponse.
 10. The system of claim 1, wherein the programming devicedetermines a source of the evoked response.
 11. The system of claim 1,wherein the programming device: records an additional evoked responseduring the implantation procedure in which the electrode array isinserted into the patient; and determines, based on the additionalevoked response, that the electrode array should be repositioned withinthe patient.
 12. The system of claim 1, wherein the programming deviceuses the evoked response to determine whether the patient is a candidatefor an electro-acoustic stimulation system.
 13. The system of claim 1,wherein the programming device notifies at least one of the patient andanother user that the residual hearing status of the patient hasdeteriorated.
 14. A system comprising: a programming system configuredto be located external to a patient; a cochlear implant system separatefrom and communicatively coupled to the programming system, the cochlearimplant system comprising a sound processor configured to locatedexternal to the patient, a cochlear implant configured to be implantedwithin the patient, and an electrode array configured to be locatedwithin a cochlea of the patient; and a receiver separate from thecochlear implant system and communicatively coupled to the programmingsystem by way of a cable that directly connects the receiver to theprogramming system, wherein the receiver is not connected directly tothe sound processor; wherein the programming system directs, during aperiod of time after an implantation procedure in which the electrodearray is inserted into the patient, at least one of the cochlear implantsystem and the receiver to apply stimulation to the patient, records anevoked response that occurs in response to the stimulation, and comparesthe evoked response to an additional evoked response previously recordedby the programming device during the period of time, determines, basedon the comparison, that a residual hearing status of the patient hasdeteriorated during the period of time, increases, in response to thedetermination that the residual hearing status of the patient hasdeteriorated during the period of time, an intensity level of additionalstimulation provided by the cochlear implant system in order to presentaudio content to the patient subsequent to the period of time,determines that the residual hearing status of the patient improvessubsequent to the period of time, and decreases, in response to thedetermination that the residual hearing status of the patient improvessubsequent to the period of time, the intensity level of the additionalstimulation provided by the cochlear implant system.
 15. The system ofclaim 14, wherein the programming system notifies at least one of thepatient and another user that the residual hearing status of the patienthas deteriorated.
 16. A method comprising: directing, by a programmingsystem, at least one of a cochlear implant system used by a patient anda receiver in communication with an ear of the patient to applystimulation to the patient, wherein the cochlear implant systemcomprising a sound processor configured to located external to thepatient, a cochlear implant configured to be implanted within thepatient, and an electrode array configured to be located within acochlea of the patient, the receiver is communicatively coupled directlyto the programming system by way of a cable that directly connects thereceiver to the programming system, and the receiver is not connecteddirectly to the sound processor, and the directing is performed during aperiod of time after an implantation procedure in which the electrodearray is inserted into the patient; recording, by the programmingsystem, an evoked response that occurs in response to the stimulation;and comparing, by the programming system, the evoked response to anadditional evoked response previously recorded by the programming deviceduring the period of time, determining, by the programming system basedon the comparison, that a residual hearing status of the patient hasdeteriorated during the period of time; increasing, by the programmingsystem in response to the determining that the residual hearing statusof the patient has deteriorated during the period of time, an intensitylevel of additional stimulation provided by the cochlear implant systemin order to present audio content to the patient subsequent to theperiod of time; determining, by the programming device, that theresidual hearing status of the patient improves subsequent to the periodof time; and decreasing, by the programming device in response to thedetermining that the residual hearing status of the patient improvessubsequent to the period of time, the intensity level of the additionalstimulation provided by the cochlear implant system.
 17. The method ofclaim 16, wherein the stimulation comprises electrical stimulation, andwherein the directing of the cochlear implant system to apply thestimulation comprises directing the cochlear implant system to apply theelectrical stimulation by way of at least one electrode included in theelectrode array.
 18. The method of claim 16, wherein the stimulationcomprises acoustic stimulation, and wherein the directing of thereceiver to apply the stimulation comprises directing the receiver toapply the acoustic stimulation to the patient.
 19. The method of claim16, wherein the stimulation comprises electrical stimulation andacoustic stimulation, and wherein the directing comprises concurrentlydirecting the cochlear implant system to apply the electricalstimulation to the patient by way of at least one electrode included inthe electrode array and the receiver to apply the acoustic stimulationto the patient.